Intravenous Infusion of Prostaglandins as Therapy in Patients With Anterior Non-arteritic Ischemic Optic Neuropathy

Phase 2

• Conditions: Ischemic Optic Neuropathy
• Interventions: Drug: Alprostadil 20 micrograms; Drug: Placebo

• Registration Number: NCT03851562
• Lead Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Brief Summary

Correction of the deficit in the perfusion pressure of the microcirculation that supplies the nerve by intravenous infusion of Prostaglandin E1 (PGE1) (Alprostadil), expected to improve visual function in patients with ischemic optic neuropathy previous non-arteritic (NOIANA).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-13
• Study First Submitted: 2019-01-11
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-21
• Study First Posted: 2019-02-22
• Last Update Submitted: 2019-02-22
• Last Update Posted: 2019-02-25
• Primary Completion: 2019-06-13
• Study Completion: 2019-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

• Patients with previous optic of any etiology in the affected eye.
• Patients with previous diagnosis or symptoms at the time of arteritis of the temporal artery.
• Patients with optic neuropathy with bilateral clinical presentation of any etiology.
• Patients with loss of vision due to acute hypotension in the context of a surgical intervention, acute hemorrhage or hemodynamic shock.
• Patients with severe loss of previous vision in the eye affected by ophthalmologic causes: severe cataract, glaucoma or intraocular pressure greater than 30 millimeters of mercury, severe diabetic retinopathy, macular degeneration associated with severe age.
• Patients with clinical onset in the month following major non-ocular or intraocular surgery
• Patients with abnormal elevation of CRP / C-reactive protein (> 2 times the upper limit of normal)
• Patients with creatinine levels above 1.5 mg / dL.
• Patients on steroid treatment in the month prior to the episode.
• Patients under treatment with oral anticoagulants.
• Patients on treatment with hydroxychloroquine, ethambutol, vigabatrin at any time before the episode.
• Patients in whom the use of PGE1 (Alprostadil) is contraindicated:
• Patients with participation in a clinical trial in the last 6 months.
• Patients with inability to understand informed consent.
• Pregnant patients, in the postpartum period or during the active lactation period.
• Physically fertile patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alprostadil 20 micrograms	Alprostadil 20 micrograms	1 μg / kg patient weight up to a maximum of 60 μg
Placebo (physiological saline solution)	Placebo	Placebo (physiological saline solution)

Primary Outcome Measures

Name	Time	Method
determination of visual acuity	Change from baseline visual acuity at 90 days.	Test ETDRS (Early Treatment Diabetic Retinopathy Study)

Secondary Outcome Measures

Name	Time	Method
Hemodynamic indices of the ocular arteries	Day1,day+30 , day +90.	Doppler SIEMENS Antares™ System:
Number of Serious Adverse Events	Day 1, day +4,day+30 , day +90.	Adverse Event
Thickness of the layer of nerve fibers and ganglion cells in the retina	Day1,day+30 , day +90.	Cirrus , Carl Zeiss Meditec, Dublin, California, ver: 6.0.2.81:
fundoscopic evaluation	Day1,day+30 , day +90.	Biomicroscopy
Intraocular Pressure	Day1,day+30 , day +90.	Intraocular Pressure
Visual Field	Day1,day+30 , day +90.	Humphrey Field Analyzer (HFA),
Optical disc area and cup / disc	Day1,day+30 , day +90.	Cirrus , Carl Zeiss Meditec, Dublin, California, ver: 6.0.2.81:

Trial Locations

Locations (1)

Hospital Clínico Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain